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Acebutolol Pregnancy and Breastfeeding Warnings

Acebutolol is also known as: Sectral

Acebutolol Pregnancy Warnings

Acebutolol has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Some studies in human pregnancy have shown decreased fetal heart rate, blood pressure, and birth weight relative to controls and patients given other antihypertensive agents. Acebutolol should only be given during pregnancy when need has been clearly established.

Acebutolol has been used safely for the treatment of maternal hypertension during pregnancy. Experience with acebutolol, especially during the first trimester, is limited. Although acebutolol crosses the human placenta, no reports of congenital malformations associated with acebutolol are reported. A controlled study comparing acebutolol to methyldopa in 20 pregnant women revealed no significant hemodynamic effect on the newborns and no differences between the drugs for pregnancy duration, birth weight, Apgar scores, or placental weight. Some studies, however, have shown that transient hypoglycemia and bradycardia are more likely in neonates whose mothers were taking acebutolol relative to mothers who were taking methyldopa. It is recommended that neonates whose mothers were taking acebutolol be monitored for signs of beta-blockade (bradycardia, hypotension, hypoglycemia) for at least 48 hours postpartum.

Acebutolol Breastfeeding Warnings

At least one nursing infant whose mother was taking acebutolol developed hypotension, bradycardia, and transient tachypnea after breast-feeding. Since acebutolol concentrates in human milk, it is recommended that nursing infants be monitored for signs and symptoms of beta-blockade during breast-feeding.

Acebutolol and its metabolite diacetolol are secreted into human milk with milk plasma ratios of 7:1 and 12:2 respectively. Side effects, such as hypotension, bradycardia, and other signs of beta-blockade have been reported in nursing infants. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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